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Carbohydrate Count Aided by a Simulation in People With Type 1 Diabetes Mellitus. A Protocol for a Clinical Trial

NCT05181917 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2024-06-06

No results posted yet for this study

Summary

Insulin remains the only approved treatment for type 1 diabetes mellitus patients and is used by many with type 2 diabetes. Carbohydrate counting is the most recommended way to prescribe prandial insulin dose because it is safe and efficacious, and also it allows a more variate diet to patients. Methods to improve carbohydrate counting include automatization of the process, optimizing carbohydrate meal content estimation, and including other nutrients such as fat into the equation. Being an iterative process that patients perfect by practicing and repeating, we believe that using simulations can improve carbohydrate counting. Simulations allow individuals to practice in a safe environment and help build confidence in one's ability to perform a task. In this clinical trial, patients assigned to the intervention group will have installed the STUDIA app, an automatic carbohydrate counter coupled to a mathematical model that simulates glucose excursions at the individual level using the patients' parameters in their smartphone. Time in range will be measured using a continuous glucose monitor.

Conditions

  • Diabetes Mellitus, Type 1

Interventions

BEHAVIORAL

STUDIA app

STUDIA application has two functions, an insulin bolus calculator that estimates the amount of insulin according to the amount of carbohydrates that the patients compute, the insulin sensitivity factor, and the insulin/carbohydrate ratio provide by their treating physician. The application has a graphical interface that shows a glucose curve four hours after the meal. . This graph is built using the estimations made by an MSBF based on some characteristics of the patient previously recorded in the same application, the amount of carbohydrates entered to calculate the insulin bolus, and an estimate of the fat and protein content of the meal.

Sponsors & Collaborators

  • Universidad de Antioquia

    collaborator OTHER

  • Hospital Pablo Tobón Uribe

    lead OTHER

Principal Investigators

  • Carlos E. Builes-Montaño, MD · Hospital Pablo Tobón Uribe

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-01
Primary Completion
2023-11-30
Completion
2023-11-30

Countries

  • Colombia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05181917 on ClinicalTrials.gov